MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER TORQVUE DELIVERY SYSTEM; CATHETER, PERCUTANEOUS

Model Number	9-ITV09F45/80
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that on (b)(6) 2025, a 9f amplatzer torqvue delivery system was selected for use.During use, saline was observed to be leaking from the system in a continuous drip at the connection between the external valve and the short extension pipe.No parts of the delivery system were observed to be damaged.The device was exchanged for a new 9f amplatzer torqvue delivery system.The patient was reported to be in good condition.
Additional Manufacturer Narrative
It was reported that during the device preparation there was a fluid leak from the delivery system was reported.The delivery system was returned to abbott for analysis.The investigation found that the extension tube contained a fracture damage.Due to the fracture damage on the extension tube, functional testing was precluded.No other anomalies were noted.As event appears to be related to a potential product quality issue; therefore, exception issue 133969 has been initiated to further investigate this complaint.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications prior to shipment.Additionally, a review of the complaint history identified no similar complaints reported from this lot.
Event or Problem Description
N/a.

• Brand Name: AMPLATZER TORQVUE DELIVERY SYSTEM
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL REG# 2135147; 5050 nathan ln n; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 23771314
• Report Number: 2135147-2025-07275
• Device Sequence Number: 9667574
• Product Code: DQY
• UDI-Device Identifier: 00811806010861
• UDI-Public: (01)00811806010861(17)271231(10)10696758
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K072313
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 9-ITV09F45/80
• Device Catalogue Number: 9-ITV09F45/80
• Device Lot Number: 10696758
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2025
• Supplement Date Received by Manufacturer: 01/30/2026
• Initial Report FDA Received Date: 12/10/2025
• Supplement Report FDA Received Date: 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/29/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown